Centocor takes lead in immunology

HORSHAM — The introduction of two products last year — Simponi and Stelara — has helped Centocor OrthoBiotech capture about a third of the $11.3 billion immunology market, and take a leadership position in the product segment over rivals Amgen and Abbott Labs, according to President Robert Bazemore.

“It’s a share we expect to continue to build,” said Bazemore, who was named president of the Johnson & Johnson subsidiary in March.

Centocor continues to be best known for Remicade, its rheumatoid arthritis medicine that generated U.S. sales of more than $4 billion last year. It has served as Centocor’s flagship product since it was approved as a treatment for Crohn’s disease in 1998.

Today, Remicade is approved for 15 indications across three disease areas: gastroenterology, rheumatology and dermatology.

“The product is still growing, and we still see a lot of opportunities for more growth,” Bazemore said.

One of those opportunities is as a treatment for pediatric ulcerative colitis. An application for that indication is expected in the “near future,” according to Centocor spokesman Brian Kenney.

Bazemore, however, believes the days of Centocor being thought of simply as a “one-product” company are over.

Last year Centocor launched Simponi and Stelara, both inflammatory-disease drugs. Simponi is a treatment for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Stelara is a treatment for adult patients with moderate-to-severe plaque psoriasis.

While both drugs target disorders that Remicade is approved to treat, they work differently from Remicade and have not “cannibalized” Remicade’s product sales, Bazemore said.

“Stelara and Simponi have their own audiences,” he said. “They have their own attributes.”

Simponi is a once-a-month injectable drug patients can administer by themselves in their own home. Remicade is typically delivered intravenously in a doctor’s office.

Stelara has a different mechanism of action from Remicade and Simponi, which reduces inflammation by targeting TNF, a natural substance made by certain blood cells in the body that when overproduced can cause the immune system to attack healthy tissues. Stelara works by blocking two cytokines, interleukin-12 and interleukin-23, which are immune-system molecules believed to be inappropriately active in the skin and joints of people with psoriasis. Stelara’s dosing requirements, after two doses during the first month of treatment, are once every 12 weeks.

“You really only need to take the drug quarterly, which is a major change in the treatment paradigm [for psoriasis],” Bazemore said.

Centocor’s new product pipeline has benefited from its 2008 merger with OrthoBiotech in New Jersey, and the subsequent acquisitions that company has made.

This summer, it bought British drug-discovery company Respivert to broaden its pipeline of pulmonary products that tackle diseases including asthma and cystic fibrosis.

Centocor also maintains a strong presence in nephrology and oncology markets with treatments like Procrit, an anemia treatment for patients with chronic kidney failure, and Doxil, used for patients with ovarian cancer that has progressed or recurred after chemotherapy.

“We’re looking to expand our footprint in oncology as evidenced by our acquisition of Cougar Biotechnology in 2009 and are excited about the continued development of abiraterone acetate — a late-stage, first-in-class compound for the treatment of prostate cancer,” Kenney said.

The launch of Stelara and Simponi came at a time when Johnson & Johnson was overhauling how its subsidiaries conduct research for new drug candidates.

Last year, Johnson & Johnson consolidated the research-and-development arms of its various drug-development companies into a single entity, called Johnson and Johnson Pharmaceutical Research and Development (J&JPRD). Subsidiaries like Centocor OrthoBiotech continue to operate as independent operating organizations under the new structure.

Sue Dillon, global therapeutic head for immunology at J&JPRD, said the R&D unit is focusing its activities on five key therapeutic areas: immunology, oncology, cardiovascular and metabolism disorders, neurology and infectious diseases and vaccines.

Under the reorganization, Centocor has 1,700 employees who handle product commercialization in two of those areas: immunology and oncology.

“For the past six years, we’ve been very interested in pulmonary disorders including asthma, chronic obstructive pulmonary disease and cystic fibrosis,” said Dillon, a Centocor researcher. “These are all diseases with large unmet needs that affect tens of millions of people.”

While Centocor has its own new drug candidates for pulmonary disorders, it acquired Respivert of London in June to broaden that pipeline.

“They have some very exciting preclinical data and are just about to go into human clinical trials,” she said.

Terms of the deal were not disclosed.

Dillon said researchers are looking to develop treatments for lupus and other inflammatory disorders, while also spending more time on translational research to better understand why certain drugs work well in some patients, but are not as effective in others.

While the research operations are now separate from the commercialization side, Dillon said, both Centocor OrthoBiotech and J&JPRD continue to work together on drug development projects.